A Safety, Efficacy Study of CombiflexOmega Peri Versus SmofKabiven Peripheral in Patients With Parenteral Nutrition (OMEGA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
JW Pharmaceutical ( JW Life Science )
ClinicalTrials.gov Identifier:
NCT01533298
First received: January 18, 2012
Last updated: February 15, 2013
Last verified: February 2013
  Purpose

The purpose of this study is to compare the safety and efficacy of CombiflexOmega peri in comparison to SmofKabiven peripheral in postoperative patients requiring parenteral nutrition.


Condition Intervention Phase
Parent
Drug: CombiflexOmega peri
Drug: SmofKabiven peripheral
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open, Multicenter, Compared Phase III Trial to Evaluate the Safety, Efficacy of CombiflexOmega Peri and SmofKabiven Peripheral in Postoperative Patients Requiring Parenteral Nutrition

Further study details as provided by JW Pharmaceutical:

Primary Outcome Measures:
  • Comparison of adverse drug reaction [ Time Frame: 4days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Changes of laboratory parameters (biochemistry, hematology, coagulation) [ Time Frame: 5days ] [ Designated as safety issue: Yes ]
  • Changes of vital signs [ Time Frame: 5days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: July 2011
Study Completion Date: January 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CombiflexOmega peri Drug: CombiflexOmega peri
intravenously over 3 days infusion
Active Comparator: SmofKabiven peripheral Drug: SmofKabiven peripheral
intravenously over 3 days infusion

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged 20 and older
  • Patients are expected to require PN for more than 3 days
  • Patients who voluntarily signed the consent form

Exclusion Criteria:

  • Patients are expected difficult to survive more than 3 days
  • Pregnant or breast-feeding women
  • BMI > 30 kg/m2
  • Patients with severe blood coagulation disorders
  • Patients with congenital amino acid metabolism disorders
  • Patients with acute shock
  • Patients with uncontrollable diabetes mellitus
  • Patients with hemophage syndrome
  • Patients with hypopotassemia (K < 3.0mEq/L)
  • Patients having the history of myocardial infarction
  • Patients reported the following laboratory value

    • fasting TG > 250mg/dl, TC > 300mg/dl
    • ALT/AST ≥ 2×ULN, Bilirubin ≥ 3mg/dl (Exception : patients with periampullary carcinoma including biliary tract or pancreas)
    • Creatinine ≥1.5mg/dl
    • Ca > 11.2mg/dl, Na ≥ 145mEq/L, Mg ≥ 2.1mEq/L, K ≥ 5.5mEq/L
  • Patients having hypersensitivity to any peanut-, fish-, soy-, egg protein, or investigational drug
  • Patients having the history of drug or alcohol abuse
  • General contraindications to infusion therapy: acute pulmonary oedema, hyperhydration, cardiac decompensation
  • Patients are in unstable conditions
  • Patients with difficult peripheral intravenous
  • Patients with parenteral nutrition within 7 days prior to start of the trial
  • Participation in another clinical study with an investigational drug or an investigational medical device within 28 days prior to start of study
  • Patients judged to be unsuitable for this trial by investigators
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01533298

Locations
Korea, Republic of
Seoul National University Bundang Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
JW Life Science
  More Information

No publications provided

Responsible Party: JW Pharmaceutical ( JW Life Science )
ClinicalTrials.gov Identifier: NCT01533298     History of Changes
Other Study ID Numbers: CW-CFO-301
Study First Received: January 18, 2012
Last Updated: February 15, 2013
Health Authority: Korea: Food and Drug Administration

ClinicalTrials.gov processed this record on August 28, 2014